There’s more tur­moil to re­port from in­side No­var­tis’ CAR-T camp.

On Fri­day Karen Walk­er will leave a se­nior po­si­tion in charge of CMC/man­u­fac­tur­ing of CAR-Ts for No­var­tis in ex­change for a new po­si­tion she’s tak­ing at Seat­tle Ge­net­ics, End­points News has learned.

Walk­er — the VP Glob­al Head Cell and Gene Ther­a­pies Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing at No­var­tis — was one of three se­nior ex­ecs put in charge of the cell and gene ther­a­py ini­tia­tive at the com­pa­ny last fall, ac­cord­ing to sources close to the com­pa­ny, af­ter a bruis­ing re­struc­tur­ing over the sum­mer in which the unit was chopped up and ab­sorbed in­side a huge R&D or­ga­ni­za­tion. Samuele Butera was put in charge of the com­mer­cial/busi­ness as­pect of the group while David Leb­wohl han­dles clin­i­cal ops.

“Karen Walk­er will join Seat­tle Ge­net­ics as Vice Pres­i­dent of Glob­al Qual­i­ty in mid-April,” con­firmed a spokesper­son for Seat­tle Ge­net­ics.

I con­tact­ed Er­ic Al­thoff, a spokesper­son for No­var­tis, Wednes­day night, but af­ter ac­knowl­edg­ing my query he did not fol­low up. Al­thoff has de­clined to re­spond to a fol­lowup query.

No­var­tis has been bleed­ing tal­ent through­out its glob­al or­ga­ni­za­tion for the past year. Walk­er’s de­par­ture, though, comes at a par­tic­u­lar­ly crit­i­cal stage for No­var­tis, just days af­ter the phar­ma gi­ant gained a pri­or­i­ty re­view for CTL019, putting it on a short path to per­haps the first his­toric ap­proval for a CAR-T.

Last sum­mer End­points broke the sto­ry about No­var­tis’ re­or­ga­ni­za­tion in CAR-T, which led the group’s top ex­ec, Us­man ‘Oz’ Azam, to leave No­var­tis. About 120 staffers were al­so ter­mi­nat­ed as the sep­a­rate group was pulled back in­to the R&D struc­ture.

No­var­tis has kept up a neck-and-neck race with Kite on the lead pro­gram, which has its own pi­o­neer­ing CAR-T head­ed to the FDA.

Man­u­fac­tur­ing in this field is crit­i­cal. To make this ther­a­py, physi­cians ex­tracts cells from can­cer pa­tients and then reengi­neer them with a chimeric anti­gen re­cep­tor to guide them to at­tack can­cer cells. The re­vised cells are then in­ject­ed back in­to pa­tients. To be com­pet­i­tive, a com­pa­ny has to prove not on­ly that they know how to make the ther­a­py, they al­so have to be able to turn it around quick­ly for use.

Magenta Therapeutics is pausing an early-stage clinical trial after a patient died. The death was deemed to be possibly related to its drug, MGTA-117.

The biotech said the pause of the Phase I/II trial is voluntary and gives it time to review all available data before deciding what to do next. It’s also reported the known information to the FDA.

The dose-escalation trial was designed to test whether MGTA-117, an antibody-drug conjugate, could serve as a more targeted alternative to high-intensity chemotherapy as a conditioning agent for cancer patients who are set to receive a stem cell transplant. It recruited patients with relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome.

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

Bristol Myers Squibb is looking to expand Breyanzi into more indications — and the pharma’s newest data readout makes progress on that front.

The Big Pharma put out word Thursday that the CAR-T cell therapy met the primary endpoint of complete response rate compared to historical control in a subset of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) that were refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Aridis Pharmaceuticals’ monoclonal antibody missed the bar in a Phase III test in ventilator-associated pneumonia caused by the gram-positive bacteria S. aureus, the company announced Wednesday. 

But Aridis is planning for a second Phase III study anyway once it discusses the findings with the FDA and the European Medicines Agency. Execs blamed recruitment challenges stemming from Covid-19 and Russia’s invasion of Ukraine for the miss, cutting their enrollment target in half.

XyloCor Therapeutics says patients with heart disease who got its gene therapy could exercise for longer and had fewer chest pain attacks. The biotech announced it completed a Phase I/II trial of the gene therapy Thursday morning, and plans to move forward with a pivotal trial.

In the Phase II portion of the trial, 28 patients with angina (or chest pain) caused by coronary artery disease and who had no other treatment options were enrolled and were given the highest tested dose from the first part of the trial. Patients were followed for six months.